A recent Wall Street Journal (WSJ) article caught my eye because it eluded to another controversy brewing at the FDA. Dr. Marciniak, a senior researcher at the FDA, has called out the FDA leadership for ignoring his deeper investigation into popular blood pressure medications known as Angiotensin Receptor Blockers (ARB’s).
Dr. Marciniak personally reviewed raw data from thousands of drug study participants to better determine if original researchers and the FDA approval boards overlooked or ignored a link between taking this popular hypertension drug with cancer.
ARB medications include:
- candesartan (Atacand)
- eprosartan (Teveten)
- irbesartan (Avapro)
- losartan (Cozaar)
- telmisartan (Micardis)
- valsartan (Diovan)
- olmesartan (Benicar)
Dr. Marciniak’s review reveals an 11% increase in cancer in those patients taking an ARB and a 25% increase in lung cancer. If you take one of these medications or have interest in how decisions about drug safety develop read on…
FDA CONCERN
Government agencies have always caught a lot of heat, perhaps for good reason. In recent weeks, the IRS has taken center stage with allegations of corruption, unconstitutional activity, profiling, and deceit. In the last few months I’ve reviewed several articles that give me serious pause regarding the FDA.
As a physician, I rely on the FDA to provide some framework and guidance when it comes to the safety of food products or medications.
But when I read articles such as:
Dispute Flares Inside FDA Over Safety of Popular Blood-Pressure Drugs (Overview on ARB issue)
Steve Nissen: The FDA Meeting On Avandia Will Be A ‘Whitewash’ (Related story on recalled diabetic drug)
I find myself wondering who to trust and what to believe? If you take the time to read through some of these articles you will notice Dr. Nissen and Dr. Marciniak have strong arguments demonstrating FDA decision makers do NOT always act in the best interest of the public. I am very uncomfortable with the second article (Avandia “whitewash”) as further digging into that story revealed very shady interactions between the FDA and Glaxosmithkline (Avandia maker) regarding a formally popular diabetic medication previously removed from the market.
Dr. Marciniak also led investigations into Avandia drug (Diabetic drug) which showed higher incidence of heart attacks. Dr. Marciniak was instrumental in uncovering the apparently falsified data used in an attempt to keep Avandia on the market. The first few pages of his FDA report are very disturbing. Dr. Marciniak shows actual patient records where heart attacks noted on clinical record were removed 15 months later — apparently to “tweak” the outcome. Now in recent months, the FDA is trying to say, upon further review, Avandia is now safe based on the same fraudulent data???? Shocking.
Clinical Delimmas
You don’t need a MD to understand my concern. I feel like a soldier, in the trench, trying to shoot my enemy (disease), only to find my bullets are either duds or worse defective. Worse yet, I’m told by those in “command” shoot anyway.
I’m not a conspiracy theorist. However, the FDA, like the IRS has some serious issues. When corruption, deception, or complacency pop into my head when I think…FDA…they might have more than just a PR problem.
Now I’m left with a frustrating decision about a ARB drugs. Do I pull patients off? Do I trust the FDA to give me a quality answer? Do I trust Dr. Marciniak and his report that shows up to a 11% increase cancer and 25% increase in lung cancer among the thousands of cases he reviewed on ARB’s? Is this another Avandia-like situation? (Of worthy note, ARB’s clinically have long been thought to not only improve blood pressure, but decrease the risk of kidney damage, and improves outcomes in heart failure patients. Furthermore the FDA has no special warnings or guidance thus far based on Dr. Marciniak’s work.)
As always, I’m only able to treat patients individually, assess risks, and counsel with the best information I have.
Cure for Clinical Delimmas
I hope these clinical musings help enlighten readers to the complexity involving medical decisions. However, I also hope this underscores the importance of avoiding “unnecessary” medications when possible. Everything in life has a risk benefit. Medication usage is a perfect example.
Some medications can save your life. Some medications can kill you. Combinations of medications or taking too many for too many problems can cause more harm than good.
What to do?
Don’t just treat symptoms…get out of the mindset that the doctor has a pill that will cure you. He might, but patients have a huge right and responsibility to cure themselves through proper nutrition, increasing physical activity, stress reduction, and focus on healthy lifestyle choices.
Sounds cliche, but it’s not. I have seen diabetes cured with proper diet. Research shows incidence of cancer and heart disease drop in those with modest routine exercise. Stress management has huge benefits for numerous medical problems according to countless studies. Doctors and patients have other options. Medications have role. Health, fitness, nutrition, and lifestyle choices play a bigger role.
As always, I hope this post was provokes thought and encourages positive actions. I will continue to monitor this topic and report back as details emerge. I welcome feedback.